RNA-based therapeutics are now at the forefront of biomedical research as pragmatic candidates for implementing precision medicine treatments. But there exists unmet need for parallel development of delivery methods to match.
NIAID invites small business grant applications proposing to test and evaluate non-viral technologies capable of delivering RNA-based therapeutics into disease-relevant cells and tissues in vivo through Notice of Special Interest (NOSI): RNA Delivery Technologies to Allow Specific Tissue Target Homing (RNA-DASH). Projects may focus on single or multiple cells or tissues, and should prioritize organs, tissues, and cell types that are clinically relevant but for which no effective in vivo delivery technologies are currently available.
The NOSI lists examples of non-viral technologies most of interest to NIAID, e.g., nano-particulate delivery systems. It also provides a list of attributes that represent potential improvements in clinical applications, e.g., minimal off-target toxicity caused by the RNA molecule or delivery system.
Note that for a proof-of-concept study, you can focus on one or more RNA-based therapeutics and one or more disease targets. We encourage programmable delivery systems.
Eyes on the Prize
At NIAID, we are especially interested in:
- Methods for specific delivery of RNA-based therapeutics to:
- Treat autoimmune diseases, allergies and asthma, hematological disorders, and immunodeficiencies.
- Increase survival of transplanted organ or cells and reduce graft versus host disease.
- Modulate the development of immune cells and functions of immune components and pathways.
- Delivery vehicles of RNA vaccines that target relevant immune cells, reformulated targeted delivery vehicles with improved adjuvant properties, or improved reactogenicity profiles.
- Methods for targeted in vivo and ex vivo delivery of RNA-based therapeutics to improve organ survival and function post-allogeneic and xenogeneic transplantation.
- Methods for specific delivery of RNA-based therapeutics to:
- Specific sites of infection, such as specific cell types, organelles, glands, organs (e.g., lung, liver, brain, testes, granulomas, specific cell types harboring pathogens, or lymph nodes) relevant for the treatment of viral, fungal, bacterial, and parasitic infections.
- Methods for specific delivery of RNA-based therapeutics to:
- HIV reservoir sites (e.g., specific cell types, lymph nodes, gut-associated lymphoid tissue, central nervous system).
- Specific sites of infection (e.g., specific cell types, lung, liver, brain, granulomas) relevant for the treatment of HIV and HIV-associated co-infections (tuberculosis, HBV, or HCV).
Note that the National Cancer Institute and National Center for Advancing Translational Sciences are also participating in this NOSI and have each identified their priority research areas in the NOSI as well.
Practical Matters
This NOSI leverages the parent small business notices of funding opportunities (NOFOs):
- PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44], Clinical Trial Not Allowed)
- PHS 2023-2: Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42], Clinical Trial Not Allowed)
To apply for this NOSI, you must submit an application through one of those NOFOs or a subsequent version (both are reissued for each new fiscal year). Constraints for your application’s budget request and project period are determined by the NOFO through which you apply.
When you apply, you must include NOT-AI-24-007 in the Agency Routing Identifier field (box 4B) of the SF 424 R&R form to be considered for this NOSI initiative.
If you have questions related to the NOSI, direct them to one of the following NIAID staff members:
- Dr. Michael Minnicozzi in our Division of Allergy, Immunology, and Transplantation at minnicozzim@niaid.nih.gov or 240-627-3532.
- Dr. Kien Nguyen in our Division of Microbiology and Infectious Diseases at kien.nguyen@nih.gov or 301-351-6229.
- Dr. Roger Ptak in our Division of AIDS at roger.ptak@nih.gov or 301-761-7424.
The next application deadline is April 5, 2024. The NOSI will remain open through January 5, 2027.